MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for POWERHEART G5 KIT, AUTO, US EN/LA ESP G5A-80A manufactured by Cardiac Science Corporation.
[188528104]
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[188528105]
Complainant alleged that during functional testing, the device failed for high impedance and did not detect the attached electrode pads. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112020-2020-00223 |
| MDR Report Key | 9904341 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERHEART G5 KIT, AUTO, US EN/LA ESP |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR |
| Product Code | MKJ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-16 |
| Model Number | G5A-80A |
| Catalog Number | G5A-80A |
| Lot Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | 500 BURDICK PARKWAY DEERFIELD WI 535319692 US 535319692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |